Prostatic Hyperplasia, Benign
Conditions
Keywords
Transperineal laser ablation, LUTS, BPO, Laser ablation
Brief summary
Rationale: With age a large group of men experience lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO). Standard treatment is a transurethral resection of the prostate or laser vaporization. As these techniques enter the prostate via the urethra, are invasive and require general or spinal anaesthesia. Transperineal laser ablation (TPLA) is a minimal invasive procedure, that can be performed under local anaesthesia. Objective: The primary objective of this study is to prove feasibility and safety of TPLA for LUTS due to BPO in healthy men. Secondary objectives: The secondary objectives are to determine functional voiding, erectile outcomes and changes on imaging.
Detailed description
This study is set up as a prospective, single centre, interventional pilot study. Eligible patients are diagnosed with LUTS due to BPO at the outpatient clinic of the department of Urology at the Academic Medical Center (AMC) and have an indication for surgical treatment. The investigators aim to include 20 patients. Eligible patients will be informed about this study by the urologist in the outpatient clinic. Information about the study will be provided both orally and in written form. The TPLA procedure is performed with the Echolaser X4 system. The system uses a diode laser source that operates at the 1064nm wavelength. The maximum energy delivered is 10 watts per laser source. The system works with the concept of thermoablation, resulting in coagulative necrosis of tissue. Two to four fibers are introduced in the prostate under untrasound vision. Ablation will be performed with 3 watts power per fibre and a total of 1200 - 1800 J will be delivered per fibre in 400 - 600 s. Follow-up will exist of four visits following surgery at 4 weeks, three, six and 12 months. The visits imply medical history, adverse event registration, physical examination (on indication) and uroflowmetry. Patient-reported outcome measures (PROMs) are used to measure functional outcomes. Used PROMs are the International Prostate Symptom Score (IPSS), International Index of Erectile Function 15 (IIEF-15), Visual Analogue Scale (VAS) and hematuria grading scale (HGS). In addition to this, imaging will exist of a contrast enhanced ultrasound (CEUS) at four weeks and 12 months.
Interventions
Minimal invasive coagulation of prostatic tissue by laser
Sponsors
Elesta S.R.L.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a prospective, single centre, interventional pilot study.
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male * ≥ 40 years of age * Peak urinary flow rate (Qmax): ≥ 5 mL/sec to ≤ 15 mL/sec, with a minimum voided volume of ≥ 125 mL, measured with uroflowmetry or urodynamic investigation * Post-void residual (PVR): ≤ 250 mL * Prostate volume: ≥ 30 and ≤ 120 cc, measured by transrectal ultrasound * Urodynamic investigation proven bladder outlet obstruction * Signed informed consent
Exclusion criteria
* Previous invasive prostate intervention (TURP, laser, ablation, etc.) * History of prostate or bladder cancer * Indwelling Foley catheter or clean intermittent catheterization (CIC) * PSA of ≥ 3.0 ng/mL without negative biopsies * Inability or unwillingness to tolerate temporary discontinuation of anticoagulation or anti-platelet therapy * Other conditions / status * Active urinary tract infection / prostatitis * Macroscopic haematuria without a known contributing factor * Poor detrusor muscle function or other neurological disorder that would impact bladder function (eg, multiple sclerosis, Parkinson's disease, spinal cord injuries, (diabetic) polyneuropathy) * Concurrent malignancy except basal skin cancer * History of lower urinary tract surgery (eg, TURP, laser, urinary diversion, artificial urinary sphincter, penile prosthesis) * History of pelvic radiation therapy or radical pelvic surgery * History of bladder neck contracture and/or urethral strictures within the 5 years prior to the informed consent date * Bladder stones * Medical contraindication for undergoing TPLA surgery (eg, infection, coagulopathy, significant cardiac or other medical risk factors for surgery) * Diagnosed or suspected bleeding disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of technical successful TPLA treatments | 24 hours following TPLA treatment | Number of technical successful performed TPLA treatments without failures related to the machine or procedure. |
| Incidence of TPLA treatment-emergent adverse events | 30 days following TPLA treatment | Number of adverse events using the CTCAE v5.0. Procedural safety is shown when there are no adverse events of grade 3 or higher. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcomes of TPLA | 12 months following TPLA treatment | Functional outcomes of TPLA measured by uroflowmetry, expressed in change of Qmax. |
| Spontaneous voiding post TPLA | 24 hours following TPLA treatment | The presence of spontaneous voiding following TPLA treatment |
| Erectile function | 12 months following TPLA treatment | To evaluate erectile function after TPLA treatment, measured by the International Index of Erectile function 15 (IIEF-15) IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; Erectile function: Q1-5 Score range 0-5 + Q15 score range 1-5, total score 1-30, higher indicates better outcome; Orgasmic function: Q9-10 Score range 0-5, total score 0-10, higher indicates better outcome; Sexual desire: Q11-12 Score range 1-5, total score 2-10, higher indicates better outcome; Intercourse satisfaction: Q6-8 Score range 0-5, total score 0-15, higher indicates better outcome; Overall satisfaction: Q13-14 Score range 1-5, total score 2-10, higher indicates better outcome; All subscale are summed to combine them to a total IIEF-15 score. |
| Antegrade ejaculation | 12 months following TPLA treatment | To evaluate antegrade ejaculation after TPLA treatment, measured by patient reporting. |
Countries
Netherlands
Outcome results
None listed